Fenspiride - instructions for use, dose, side effects, contraindications

Active substance:
Fenspiride hydrochloride	80.0 mg
Excipients:
Calcium hydrogen phosphate dihydrate	104.5 mg
Hypromellose	100.0 mg
Crospovidone	12.8 mg
Silica colloidal dioxide	0.5 mg
Magnesium stearate	2.2 mg
Shell:
Opadry II Yellow 85F32771 (polyvinyl alcohol 35.0-49.0%, talc - 9.80 - 25.0%, macrogol 3350 - 7.35 - 35.2%, titanium dioxide and iron oxide yellow - 15.15 - 30.0%)	6.0 mg

Description:

Round, biconvex tablets, covered with a film coating of light yellow color. On the cross section, the nucleus is white or almost white in color.

Pharmacotherapeutic group:anti-inflammatory anti-bronchoconstrictive agent

ATX: & nbsp

R.03.D.X.03 Fenspiride

Pharmacodynamics:

Anti-inflammatory and anti-bronchoconstrictive activity is due to the fact that fenspiride reduces the production of a number of biologically active substances (cytokines, especially tumor necrosis factor a (TNF-α), arachidonic acid derivatives, free radicals) that play an important role in the development of inflammation and bronchospasm. Inhibition of fenspiride metabolism of arachidonic acid is potentiated by its H₁-antigistamine action, since histamine stimulates the formation of its products (prostaglandins and leukotrienes). Fenspiride blocks α-adrenergic receptors, stimulation of which is accompanied by an increase in the secretion of bronchial glands. In this way, fenspiride reduces the effect of a number of factors that contribute to the hypersecretion of proinflammatory factors, the development of inflammation and bronchial obstruction. Fenspiride also has an antispasmodic effect.

Pharmacokinetics:

Suction

Fenspiride is absorbed relatively slowly in the gastrointestinal tract.The maximum concentration after ingestion is reached after 6 hours.

Excretion

It is excreted mainly by the kidneys. The half-life is 12 hours.

Indications:

1. Diseases of the upper and lower respiratory tract:

- rhinopharyngitis and laryngitis;

- tracheobronchitis;

- bronchitis (in the background of chronic respiratory failure or without it);

- bronchial asthma (as part of complex therapy);

- respiratory effects (cough, hoarseness, throat swelling) with measles, whooping cough and flu;

- with infectious diseases of the respiratory tract accompanied by a cough, when the standard antibiotic treatment is shown.

2. Otitis and sinusitis of various etiologies.

Contraindications:

- Hypersensitivity to the active substance and / or any of the components of the drug.

- Pregnancy, the period of breastfeeding.

- Children under 18 years.

Pregnancy and lactation:

Data on the use of fenspiride in pregnant women are absent or limited. The use of fenspiride during pregnancy is not recommended.

Therapy with fenspiride is not a reason for interrupting the pregnancy that has occurred.

Do not use the drug Fenspiride during breastfeeding due to the lack of data on the penetration of fenspiride into breast milk.

Dosing and Administration:

Inside.

Adults: 1 tablet 2-3 times a day.

The maximum daily dose is 240 mg.

The duration of treatment is determined by the doctor.

Side effects:

Most often when using fenspirid, there are undesirable reactions from the gastrointestinal tract.

The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems. The frequency of occurrence of undesirable reactions is estimated as follows: arising "very often" -> 1/10; "often" -> 1/100 and <1/10, "infrequently" -> 1/1000 and <1/100, "rarely" -> 1/10000 and <1/1000, "very rarely" - <1 / 10000, including individual messages, "frequency unknown" - according to available data, it was not possible to establish the frequency of occurrence.

Disturbances from the nervous system: rarely - drowsiness; frequency unknown - dizziness.

Heart Disease: rarely - moderate tachycardia, the severity of which decreases with a decrease in the dose of fenspiride; frequency unknown - a palpitation, a decrease in blood pressure, possibly associated with tachycardia.

Disorders from the gastrointestinal tract: often - gastrointestinal disorders, nausea, epigastric pain; frequency unknown - diarrhea, vomiting.

Disturbances from the skin and subcutaneous tissues: rarely - erythema, rash, hives, angioedema, fixed erythema pigmentosa; frequency unknown - pruritus, toxic epidermal necrolysis, Stevens-Johnson syndrome.

General disorders and disorders at the site of administration: frequency unknown - asthenia, increased fatigue.

If any of the unwanted reactions listed in the manual is aggravated, or if you notice any other undesirable reactions not listed in the instructions, inform the doctor about it.

Overdose:

There are cases of overdose with fenspiride in a dose of more than 2320 mg. If an overdose of fenspiride should immediately seek medical help.

Symptoms: drowsiness or agitation, nausea, vomiting, sinus tachycardia.

Treatment: gastric lavage, electrocardiogram monitoring (ECG), maintenance of vital body functions.

Interaction:

Special studies on the interaction of fenspiride with other drugs have not been conducted.

Because of the possible increase in sedation with the use of blockers, H₁-gistaminovyh receptors do not recommend the use of the drug Fenspiride in combination with drugs that have a sedative effect, or in combination with alcohol.

Special instructions:

For the treatment of adolescents and children, appropriate dosage forms of preparations containing fenspiride.

Treatment with fenspiride does not replace antibacterial therapy and can not cause a delay in the proper use of antibacterial drugs.

Effect on the ability to drive transp. cf. and fur:

Studies to study the effect of fenspiride on the ability to drive vehicles and work with mechanisms have not been conducted. Patients should be aware of the possible development of drowsiness when taking the drug Fenspiride especially at the beginning of therapy or when combined with alcohol intake and should be careful when driving vehicles and performing work that requires a high rate of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 80 mg.

Packaging:

For 10 or 15 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil foil.

2 contour cell packs (15 tablets each) or 3 out-of-round cell packs (10 tablets each) together with instructions for use in a cardboard pack.

For 30 tablets in polyethylene terephthalate bottles, sealed with polyethylene caps. 1 bottle with instructions for use in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003833

Date of registration:14.09.2016

Expiration Date:14.09.2021

The owner of the registration certificate:NATIVA, LLC NATIVA, LLC Russia

Manufacturer: & nbsp

NATIVA, LLC Russia

FARMSTANDART-UFAVITA, JSC Russia

Representation: & nbspPHARMSTANDART-Ufa-VITA, JSCPHARMSTANDART-Ufa-VITA, JSC

Information update date: & nbsp29.09.2016

Illustrated instructions

Instructions

Fenspiride (Fenspiride)